Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

Supplemental Material - Linked Child Welfare and Medicaid Data in Kentucky and Florida Highlights Racial Disparities in Access to Care

Supplemental Material for Linked Child Welfare and Medicaid Data in Kentucky and Florida Highlights Racial Disparities in Access to Care by Tami L. Mark, Melissa Dolan, Benjamin Allaire, William Parish, Diana Poehler, Clark Strack, Emily Madden, and Valeria Butler in Child Maltreatment</p

The Difficult Reception of Rigorous Descriptive Social Science in the Law

Mutual disdain is an effective border patrol at the demarcation lines between disciplines. Social scientists tend to react with disdain when they observe how their findings are routinely stripped of all the caveats, assumptions and careful limitations once they travel into law. Likewise, lawyers tend to react with disdain when they read all the laborious proofs and checks for what looks to them like a minuscule detail in a much larger picture. But mutual disdain comes at a high price. All cross-border intellectual trade is stifled. This paper explores the social science/law border from the legal side. The natural barriers turn out to be significant, but not insurmountable.Specifically the paper looks at the challenges of integrating rigorous descriptive social science into the application of the law in force by courts and administrative authorities. This is where the gap is most difficult to bridge. The main impediments are implicit value judgments inherent in models, conceptual languages and strictly controlled ways of generating empirical evidence; the difference between explanation, hypothesis testing and prediction, on the one hand, and decision-making, on the other; the ensuing difference between theoretical and practical reasoning, and the judicial tradition of engaging in holistic thinking; last but not least, the strife of the legal system for autonomy, in order to maintain its viability.If a legal academic assumes the position of an outside observer, she may entirely ignore all these concerns and simply follow the methodological standards of descriptive social science. This is, for instance, what most of law and economics does. The legal academic may, instead, choose to contribute to the making of new law. She will then find it advisable to partly ignore the strictures of rigorous methodology in order to be open to more aspects of the regulatory issue. But it is not difficult, at least, to follow the standards of the social sciences for analysing the core problem. The integration is most difficult if an academic does doctrinal work. But it is precisely here where the division of intellectual labour between legal practice and legal academia is most important. Academics who themselves are versatile in the respective social science translate the decisive insights into suggestions for a better reading of statutory provisions or case law